Business Development & Sales Manager

Role Purpose

The Business Development & Sales Manager will drive commercial growth and strategic expansion for Holostem’s ATMP portfolio, including Holoclar® and pipeline assets. The role combines business development, sales execution, and strategic partnership development, with a strong focus on treatment centre engagement, market access, and regulatory‑aware commercialisation models specific to ATMPs.

The successful candidate will act as a key interface between commercial strategy and operational delivery, leveraging Holostem’s experience with Holoclar® as a benchmark for excellence in ATMP market access, supply coordination, and stakeholder engagement.

Reporting Line

Chief Operating Officer (COO)

Location

Italy (with extensive European and international travel)

Key Responsibilities

Commercial & Business Development

• Implement business development and commercial strategies as agreed with the Chief Operating Officer, building on the proven commercialization framework established with Holoclar®.
• Drive sales performance in assigned territories, supporting adoption of Holostem therapies at authorised and emerging treatment centres.
• Identify, qualify, and onboard new treatment centres, ensuring readiness in line with ATMP regulatory and operational requirements.
• Define, negotiate, and maintain supply and commercial agreements with treatment centres, reflecting the controlled supply and traceability models required for products such as Holoclar®.
• Ensure accurate forecasting and demand planning, aligned with manufacturing capacity and clinical scheduling.

Strategic Growth & Market Expansion

• Identify and evaluate strategic growth opportunities across European and selected international markets, including:
  • Partnerships and institutional collaborations
  • Licensing and co‑development opportunities
  • Distribution and access models tailored to ATMPs
• Scout and analyse regulatory, competitive, and reimbursement environments, using the Holoclar® experience as a reference point for risk mitigation and opportunity assessment.
• Propose and implement market‑specific strategies that support sustainable expansion while maintaining compliance with EMA and national frameworks.

Stakeholder & Relationship Management

• Build and maintain strong relationships with key stakeholders at treatment centres, including clinicians, surgeons, pharmacists, procurement teams, and hospital management.
• Act as a trusted commercial and scientific partner, supporting appropriate patient access to Holoclar® and future therapies.
• Ensure consistent engagement with key opinion leaders (KOLs) in regenerative medicine and ATMPs.

Cross‑Functional Collaboration

• Collaborate closely with Scientific, Regulatory, Quality, Client Services, Manufacturing, Clinical, Supply Chain, and Finance teams to:
  • Align commercial opportunities with operational and manufacturing readiness
  • Support regulatory compliance and post‑authorization commitments linked to Holoclar®
  • Ensure timely, compliant delivery of therapies to treatment centres
• Support internal decision‑making with market insights derived from field activities.

External Representation

• Represent Holostem at international conferences, scientific congresses, partnering events, and investor meetings, positioning Holoclar® as a reference ATMP success story.
• Increase company visibility and generate qualified commercial and strategic leads across Europe and beyond.

Qualifications & Experience

Education

• PhD in Life Sciences or a relevant scientific discipline (required).
• MBA or equivalent business education is a plus but not mandatory.

Professional Experience

• Proven experience in business development, sales, or strategic consultancy within biotech, pharma, or advanced therapies.
• Direct experience with ATMPs, regenerative medicine, stem cell or cell‑based therapies; familiarity with Holoclar® or similar hospital‑based ATMP models is a strong advantage.
• Solid understanding of the EMA regulatory framework, including centralized authorization and post‑marketing obligations.

Technical & Business Skills

• Knowledge of pharmaceutical and ATMP operations, including manufacturing‑commercial interfaces.
• Experience with forecasting, contract negotiation, and partnership structuring.
• Ability to assess complex regulatory and market environments and translate insights into actionable commercial strategies.
• Basic computer literacy; experience with CRM and reporting tools preferred.

Language Requirements

• Fluent written and spoken English (mandatory).
• Fluent written and spoken Italian (mandatory).
• Additional European languages are a plus.

Personal Attributes

• Strategic yet hands‑on mindset, comfortable operating in a high‑innovation, regulated ATMP environment.
• Strong interpersonal and negotiation skills, with the ability to engage credibly with scientific, clinical, and executive stakeholders.
• High level of autonomy, resilience, and willingness to travel extensively.
• Strong ethical standards and commitment to patient‑centric commercialisation.

What Holostem Offers

• A pivotal role in a company with a landmark ATMP success story (Holoclar®) and an expanding pipeline.
• Exposure to cutting‑edge regenerative medicine and advanced cell‑based therapies.
• Direct interaction with senior leadership and influence on commercial and corporate strategy.
• Competitive compensation package aligned with experience and performance.

The position is open to both genders (L.903/77 – D.Lgs. n.198/2006).